Benefit of a 2-month treatment with a micronized, purified flavonoidic fraction on venous ulcer healing. A randomized, double-blind, controlled versus placebo trial.
OBJECTIVE
To assess the efficacy of a micronized purified flavonoid fraction (Daflon 500 mg = Dios) in venous leg ulcer healing, in addition to compression therapy and standardized local care.


METHODS
Double-blind, multicentre, randomized, parallel groups, controlled versus placebo trial; stratification according to ulcer size.


METHODS
107 patients, with venous ulcer of the leg for at least 3 months, and accepting bandaging therapy.


RESULTS
105 patients (Dios = 53, placebo = 52) were available for an intention to treat (ITT) analysis. Age (mean +/- SD, 71+/-11 years), gender (M = 33, F = 74) and ulcer size were evenly distributed among both groups. 99 patients completed the protocol (Dios = 51, placebo = 48). Among the 91 patients with ulcer size < or = 100 cm (Dios = 44, placebo = 47), a significantly higher number of patients had complete ulcer healing at 2 months in the Dios group (n = 14) in comparison to the placebo group (n = 6) after ITT analysis (32 vs. 13%, p = 0.028) and after per protocol analysis (32 vs. 14%, p = 0.048), and a shorter time duration of healing (p = 0.037). Among the 14 patients with ulcer size > 10 cm (Dios = 9, placebo = 5), no ulcer healed.


CONCLUSIONS
This study showed that a 2-month course of purified micronized flavonoid fraction (2 tablets/day), in addition to conventional treatment, is of benefit in patients by accelerating complete healing of venous leg ulcers which are < or = 10 cm in diameter.
Guilhou
J J
JJ
Dermatology-Phlebology Department, Hôpital Saint-Charles, Montpellier, France.
Février
F
F
Debure
C
C
Dubeaux
D
D
Gillet-Terver
M N
MN
Guillot
B
B
Levesque
H
H
Marzin
L
L
Mignot
J
J
Ouvry
P
P
Pillion
G
G
Van Landuyt
H
H
Zuccarelli
F
F
Nicolaïdes
A N
AN
D000293:Adolescent; D000328:Adult; D000368:Aged; D004145:Diosmin / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006569:Hesperidin / Q000627:therapeutic use*; D006801:Humans; D007871:Leg Ulcer / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D014689:Venous Insufficiency / Q000188:drug therapy*; D014945:Wound Healing / Q000187:drug effects*
D004338:Drug Combinations; D004145:Diosmin; D006569:Hesperidin